Shikani Middle Meatal Antrostomy Vent Tube
FDA 510(k) K912418 · Micromedics, Inc.
510(k) numberK912418
Submission
- Device name
- Shikani Middle Meatal Antrostomy Vent Tube
- Applicant
- Micromedics, Inc.
St. Paul, MN, US - Received
- May 31, 1991
- Decision date
- December 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KAM – Cannula, Sinus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110687 | Relieva Stratus Pro Microflow Spacer (Frontal)KAM · Special | Acclarent, Inc. | 10/07/2011SE |
| K093594 | Modification to Relieva Stratus Microflow SpacerKAM · Special | Acclarent, Inc. | 03/03/2010SE |
| K083574 | Relieva Stratus Microflow SpacerKAM · Traditional | Acclarent, Inc. | 01/29/2009SE |
| K072891 | Sinus SpacerKAM · Traditional | Acclarent, Inc. | 03/19/2008SE |
| K073041 | Relieva and Relieva Acella Sinus Balloon CatheterKAM · Traditional | Acclarent, Inc. | 03/11/2008SE |
| K071845 | Relieva Luma Sinus Illumination System, Model SIS-100AKAM · Traditional | Acclarent, Inc. | 09/28/2007SE |
| K062458 | Ethmoid Sinus SpacerKAM · Traditional | Acclarent, Inc. | 09/15/2006SE |
| K060974 | Relient Navigation DeviceKAM · Special | Acclarent, Inc. | 05/05/2006SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | Micromedics, Inc. | 04/27/2005SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | Xomed, Inc. | 02/08/2000SE |
More from Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | 07/15/2024SE |
| K123847 | Malleable Tip Endoscopic ApplicatorGCJ · Special | 01/08/2013SE |
| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | 04/27/2005SE |
Questions and answers
When was Shikani Middle Meatal Antrostomy Vent Tube cleared by the FDA?
Shikani Middle Meatal Antrostomy Vent Tube (K912418) received a 510(k) decision of Substantially Equivalent on December 20, 1991, 203 days after the submission was received.
What is the product code of K912418?
The FDA product code is KAM – Cannula, Sinus, a Class I (low risk) device regulated under 21 CFR 878.4800.